{"id":"xen1101","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Dizziness"},{"rate":"5-10%","effect":"Nausea"},{"rate":"5-10%","effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By blocking the Nav1.7 sodium channel, XEN1101 is intended to reduce pain by inhibiting the transmission of pain signals in the nervous system.","oneSentence":"XEN1101 is a selective Nav1.7 sodium channel blocker.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:41:10.238Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of trigeminal neuralgia"}]},"trialDetails":[{"nctId":"NCT05614063","phase":"PHASE3","title":"A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures","status":"COMPLETED","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2022-11-18","conditions":"Focal Onset Seizures","enrollment":380},{"nctId":"NCT05667142","phase":"PHASE3","title":"A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures","status":"RECRUITING","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2023-02-14","conditions":"Primary Generalized Tonic-Clonic Seizures","enrollment":160},{"nctId":"NCT05716100","phase":"PHASE3","title":"A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)","status":"RECRUITING","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2023-05-09","conditions":"Focal Onset Seizures","enrollment":360},{"nctId":"NCT05718817","phase":"PHASE3","title":"An Open-label Study of XEN1101 in Epilepsy","status":"ENROLLING_BY_INVITATION","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2023-04-25","conditions":"Focal Epilepsy, Tonic-Clonic Seizures","enrollment":880},{"nctId":"NCT07217860","phase":"PHASE3","title":"An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)","status":"ENROLLING_BY_INVITATION","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2025-10-30","conditions":"Bipolar Depression, Bipolar I Disorder, Bipolar Disorder","enrollment":400},{"nctId":"NCT06922110","phase":"PHASE3","title":"An Open-Label Study of Azetukalner in Major Depressive Disorder","status":"ENROLLING_BY_INVITATION","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2025-03-18","conditions":"Major Depressive Disorder","enrollment":460},{"nctId":"NCT07172516","phase":"PHASE3","title":"A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","status":"RECRUITING","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2025-08-08","conditions":"Bipolar Disorder, Bipolar Depression, Bipolar I Disorder","enrollment":400},{"nctId":"NCT07076407","phase":"PHASE3","title":"A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)","status":"RECRUITING","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2025-07-08","conditions":"Major Depressive Disorder","enrollment":450},{"nctId":"NCT06775379","phase":"PHASE3","title":"A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder","status":"RECRUITING","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2024-12-20","conditions":"Major Depressive Disorder","enrollment":450},{"nctId":"NCT04827901","phase":"PHASE2","title":"XEN1101 for Major Depressive Disorder","status":"COMPLETED","sponsor":"James Murrough","startDate":"2021-10-19","conditions":"Major Depressive Disorder","enrollment":44},{"nctId":"NCT03796962","phase":"PHASE2","title":"A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2019-01-30","conditions":"Focal Epilepsy","enrollment":325},{"nctId":"NCT05376150","phase":"PHASE2","title":"A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder","status":"COMPLETED","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2022-05-19","conditions":"Major Depressive Disorder","enrollment":168},{"nctId":"NCT03340220","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.","status":"COMPLETED","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2017-11-13","conditions":"Healthy Volunteers","enrollment":130},{"nctId":"NCT04952467","phase":"PHASE1","title":"Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101","status":"COMPLETED","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2021-07-14","conditions":"Healthy Volunteers","enrollment":6},{"nctId":"NCT03468725","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101","status":"COMPLETED","sponsor":"Xenon Pharmaceuticals Inc.","startDate":"2018-02-13","conditions":"Healthy Male Volunteers","enrollment":20}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Azetukalner"],"phase":"phase_3","status":"active","brandName":"XEN1101","genericName":"XEN1101","companyName":"Xenon Pharmaceuticals Inc.","companyId":"xenon-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"XEN1101 is a selective Nav1.7 sodium channel blocker. Used for Treatment of trigeminal neuralgia.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}